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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040942
Receipt No. R000046742
Scientific Title Effects of occlusal habit on pain sensitivityand occlusal dysesthesia
Date of disclosure of the study information 2020/07/07
Last modified on 2020/06/29

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Basic information
Public title Effects of occlusal habit on pain sensitivityand occlusal dysesthesia
Acronym Relationship between occlusal habit and pain
Scientific Title Effects of occlusal habit on pain sensitivityand occlusal dysesthesia
Scientific Title:Acronym Effects of occlusal habit on pain sensitivity
Region
Japan

Condition
Condition Temporomandibular disorder
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of interaction between eccentric exercise and clenching exercise on pain sensitivity
Basic objectives2 Others
Basic objectives -Others To examine the effects of preloading eccentric exercise on pain sensitivity after clenching exercise
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain intensity induced by electrical stimuli using visual analog scale (VAS):before and after each exercise
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 eccentric exercise performed using a jaw opening device and voluntary clenching exercise
Interventions/Control_2 gum chewing exercise and voluntary clenching exercise
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria healthy adult volunteers
Key exclusion criteria symptoms of temporomandibular disorder, neurological disorders or abnormalities in stomatognatic, neck and shoulder function, daily headache, awareness of bruxism, functional pain or pain by palpation in the muscles of the orofacial region or temporomandibular joint, use of pain medicine within 1 month
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tetsurou
Middle name
Last name Torisu
Organization Nagasaki University
Division name Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences
Zip code 8528588
Address 1-7-1 Sakamoto, Nagasaki
TEL 0958197692
Email torisu@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Tetsurou
Middle name
Last name Torisu
Organization Nagasaki University
Division name Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences
Zip code 8528588
Address 1-7-1 Sakamoto, Nagasaki
TEL 0958197692
Homepage URL
Email torisu@nagasaki-u.ac.jp

Sponsor
Institute Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor 1.Department of Oral Health Sciences, KU Leuven,Belgium
2.Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethics committee of Nagasaki University Graduate School of Medicine and Dentistry
Address 1-7-1, Sakamoto, Nagasaki
Tel 0958197229
Email gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1007/s10266-020-00516-w
Number of participants that the trial has enrolled 20
Results
The degree of temporal summation of pain after clenching induced by repeated electrical stimulation to the masseter muscle showed statistically significant increases 2 days after the exercise only in the eccentric condition of the preloading exercises but not in the gum chewing condition.
 It was demonstrated that pain sensitivity after the low-level clenching could be influenced by the type of the preloading exercise.
Results date posted
2020 Year 06 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 04 Month 09 Day
Baseline Characteristics
Participant flow
Adverse events
non
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 03 Month 07 Day
Date of IRB
2014 Year 04 Month 09 Day
Anticipated trial start date
2015 Year 04 Month 06 Day
Last follow-up date
2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 01 Month 17 Day

Other
Other related information

Management information
Registered date
2020 Year 06 Month 29 Day
Last modified on
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046742

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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